[Federal Register Volume 74, Number 41 (Wednesday, March 4, 2009)]
[Rules and Regulations]
[Pages 9365-9367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4364]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1106; FRL-8402-7]


Chlorothalonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of chlorothalonil and its 4-hydroxy metabolite in or on lychee and 
starfruit. The United States Department of Agriculture (USDA) requested 
that EPA establish these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective March 4, 2009. Objections and 
requests for hearings must be received on or before May 4, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-1106. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2007-1106 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before May 4, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-1106, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background

    In the Federal Register of December 3, 2008 (73 FR 73632) (FRL-
8390-1), EPA issued a proposed rule pursuant to sections 408(e) of 
FFDCA, 21 U.S.C. 346a(d)(3). The rule proposed that 40 CFR 180.275 be 
amended by establishing tolerances for combined residues of 
chlorothalonil and its 4-hydroxy metabolite in or on lychee at 15 parts 
per million (ppm) and starfruit at 3.0 ppm. The USDA requested that EPA 
establish these tolerances. Because USDA did not submit a petition in 
support of establishing these tolerances, EPA did not publish a Notice 
of Filing of a petition for these tolerances. Rather, EPA issued a 
proposed rule that included a summary of the exposure assessment 
prepared by the Agency and explained the basis for EPA's conclusion 
that there is a reasonable certainty that no harm will result to the 
general population, or to infants and children, from aggregate exposure 
to chlorothalonil. The proposal established a 60-day public comment 
period. Comments were received in response to the proposed rule. EPA's 
response to these comments is discussed in Unit III.

[[Page 9366]]

III. Response to Comments

    Comments were received in response to the proposed rule from two 
United States citizens. The comments and EPA's response are presented 
below:
    An anonymous citizen objected to the presence of any pesticide 
residues on crops and stated that EPA should set no pesticide tolerance 
greater than zero. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned completely. However, the existing legal framework provided by 
section 408 of FFDCA contemplates that tolerances greater than zero may 
be set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. This citizen's comment appears to be directed at the 
underlying statute and not EPA's implementation of it; the citizen has 
made no contention that EPA has acted in violation of the statutory 
framework.
    A second citizen indicated her support for the tolerances on lychee 
and starfruit based on EPA's determination that the proposed tolerance 
levels are safe, but, at the same time, expressed hope that all 
pesticide residues will eventually be removed from food. The commenter 
also expressed ``great'' concern about the carcinogenicity of 
chlorothalonil, notwithstanding EPA's determination that the cancer 
risk is below the level of concern; and voiced concerns that EPA's risk 
assessment for chlorothalonil did not adequately address the risks of 
cancer from ``aggregate'' residues of multiple pesticides on food.
    The Agency understands the commenter's concerns about establishing 
food tolerances for pesticides that have the potential to cause cancer. 
Prior to establishing such tolerances, EPA conducts an aggregate 
exposure assessment to evaluate cancer risk to ensure that the 
tolerance meets the safety standard of a ``reasonable certainty of no 
harm'' established by FFDCA. The cancer effect observed in 
chlorothalonil animal studies is believed to be a threshold effect 
resulting from a non-linear mode of action. In the case of a threshold 
effect for a pesticide, EPA considers that a tolerance will provide a 
``reasonable certainty of no harm'' if the aggregate exposure to the 
pesticide residue is lower by an ample margin of safety than the level 
at which the pesticide will not cause or contribute to any known or 
anticipated harm to human health. Aggregate exposures that are at least 
100-fold lower than the no observable adverse effect level (NOAEL) are 
considered to provide an ample margin of safety when data are 
extrapolated from animals. The aggregate exposure assessment conducted 
to evaluate cancer risk for chlorothalonil indicates that aggregate 
exposures are more than 100-fold lower than the NOAEL for 
chlorothalonil; therefore, EPA has concluded that the proposed 
tolerances are acceptable.
    EPA disagrees with the comment that the chlorothalonil risk 
assessment did not adequately address cancer risk from residues of 
multiple pesticides on food. The Agency is required by section 408 of 
FFDCA to consider available information concerning the cumulative 
toxicological effects of the residues of a pesticide and of other 
substances having a common mechanism of toxicity with it. This 
requirement applies to all types of toxicological effects, including 
cancer. At this time, EPA has not identified any other substances 
having a common mechanism of carcinogenicity with chlorothalonil. 
Therefore, EPA did evaluate potential cancer risk from exposure to 
chlorothalonil and other pesticides.

IV. Conclusion

    Based on the information, analysis, and conclusions in the December 
3, 2008 proposal (73 FR 73632) (FRL-8390-1), tolerances are established 
for residues of chlorothalonil, tetrachloroisophthalonitrile, and its 
metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on lychee 
at 15 ppm and starfruit at 3.0 ppm.

V. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA on EPA's own initiaive. The Office of Management and Budget (OMB) 
has exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency hereby certifies that this rule will not have 
significant negative economic impact on a substantial number of small 
entities. Establishing a pesticide tolerance or an exemption from the 
requirement of a pesticide tolerance is, in effect, the removal of a 
regulatory restriction on pesticide residues in food, and thus such an 
action will not have any negative economic impact on any entities, 
including small entities.
    In addition, the Agency has determined that this action will not 
have a substantial direct effect on States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132, entitled Federalism (64 FR 43255, 
August 10, 1999). Executive Order 13132 requires EPA to develop an 
accountable process to ensure ``meaningful and timely input by State 
and local officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications''

[[Page 9367]]

as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (59 FR 22951, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: February 12, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


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2. Section 180.275 is amended by alphabetically adding the following 
commodities to the table in paragraph (a)(1) to read as follows:


Sec.  180.275  Chlorothalonil; tolerances for residues.

    (a) * * *
    (1) * * *

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                       Commodity                                            Parts per million
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                                                    * * * * *
Lychee................................................                                                        15
                                                    * * * * *
Starfruit.............................................                                                       3.0
                                                    * * * * *
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[FR Doc. E9-4364 Filed 3-3-09; 8:45 am]
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